Drug Interaction Report

CONTRAINDICATED: The central nervous system and respiratory depressant effects of sodium oxybate, which is the sodium salt of gamma hydroxybutyrate (GHB), may be potentiated by concomitant use of sedative-hypnotic agents. An increased risk of serious adverse reactions such as respiratory depression, hypotension, profound sedation, syncope, coma, and even death should be anticipated.

MANAGEMENT: The use of sodium oxybate in combination with sedative-hypnotic agents is considered contraindicated.

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GENERALLY AVOID: The central nervous system and respiratory depressant effects of sodium oxybate, which is the sodium salt of gamma hydroxybutyrate (GHB), may be potentiated by concomitant use of other agents with CNS depressant effects. An increased risk of serious adverse reactions such as respiratory depression, hypotension, profound sedation, syncope, coma, and even death should be considered.

MANAGEMENT: Concomitant use of sodium oxybate with other CNS depressants should be avoided whenever possible. Otherwise, close monitoring and/or dosage reductions should be considered. If short-term use of a CNS depressant is required (e.g., post- or perioperative opioid), a temporary interruption of sodium oxybate therapy may be appropriate. All patients treated with sodium oxybate should be advised not to drive, operate machinery, or engage in potentially hazardous activities requiring mental alertness and motor coordination for at least 6 hours after taking the second nightly dose of sodium oxybate and until they know how the medication affects them.

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MONITOR: Central nervous system- and/or respiratory-depressant effects may be additively or synergistically increased in patients taking multiple drugs that cause these effects, especially in elderly or debilitated patients. Sedation and impairment of attention, judgment, thinking, and psychomotor skills may increase.

MANAGEMENT: During concomitant use of these drugs, patients should be monitored for potentially excessive or prolonged CNS and respiratory depression. Cautious dosage titration may be required, particularly at treatment initiation. Ambulatory patients should be counseled to avoid hazardous activities requiring mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

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CONTRAINDICATED: Alcohol may potentiate the central nervous system and respiratory depressant effects of sodium oxybate, which is the sodium salt of gamma hydroxybutyrate (GHB). An increased risk of serious adverse reactions such as respiratory depression, hypotension, profound sedation, syncope, coma, and even death should be anticipated.

ADJUST DOSING INTERVAL: Food may delay the absorption and significantly decrease the bioavailability of sodium oxybate. When sodium oxybate was administered immediately after a high-fat meal, the time to reach peak plasma concentration (Tmax) increased from 0.75 hour to 2 hours, the peak plasma concentration (Cmax) decreased by a mean of 59%, and the systemic exposure (AUC) decreased by a mean of 37%.

MANAGEMENT: The concomitant use of sodium oxybate with alcohol is considered contraindicated. The first dose of sodium oxybate should be taken at least 2 hours after a meal to ensure maximal absorption.

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GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

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GENERALLY AVOID: Acute ethanol ingestion may potentiate the CNS effects of many benzodiazepines. Tolerance may develop with chronic ethanol use. The mechanism may be decreased clearance of the benzodiazepines because of CYP450 hepatic enzyme inhibition. Also, it has been suggested that the cognitive deficits induced by benzodiazepines may be increased in patients who chronically consume large amounts of alcohol.

MANAGEMENT: Patients should be advised to avoid alcohol during benzodiazepine therapy.

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